Bedaquiline Fumarate and Kuvan (Sapropterin Tablets)

• Generic Name: bedaquiline
• Dosage Forms: n.a.
• Other Brand Names: Sirturo

Treatment of pulmonary multidrug-resistant tuberculosis (i.e., caused by Mycobacterium tuberculosis resistant to isoniazid and rifampin) in conjunction with other antituberculosis agents.

Designated an orphan drug by FDA for use in treatment of active tuberculosis.

Use only when an effective treatment regimen for multidrug-resistant tuberculosis cannot otherwise be provided.

Safety and efficacy for treatment of drug-susceptible tuberculosis, extrapulmonary (e.g., CNS) tuberculosis, or latent tuberculosis infection not established; use not recommended.

Safety and efficacy for treatment of infections caused by nontuberculous mycobacteria (NTM) not established; use not recommended.

Patients with multidrug-resistant tuberculosis are at high risk for treatment failure and acquisition of further drug resistance. ATS, CDC, and IDSA recommend that such patients be referred to or that consultation be obtained from a specialized treatment center as identified by local or state health departments or the CDC.

• Generic Name: sapropterin
• Dosage Forms: tablet; powder, for oral solution
• Other Brand Names: Kuvan

• It is used to treat phenylketonuria (PKU).